WALTHAM, Mass. and OSAKA, Japan, Dec. 29, 2014 (GLOBE NEWSWIRE) -- AMAG
Pharmaceuticals (Nasdaq:AMAG) and Takeda Pharmaceutical Company Limited
(Takeda) announced today that they have entered into an agreement to
mutually terminate the March 2010 license, development and
commercialization agreement, which granted Takeda exclusive rights to
market ferumoxytol in Canada, the European Union (EU) and Switzerland,
as well as certain other geographic territories (under the trade name
Rienso(R) outside of Canada where the product's trade name is
Feraheme(R)).
Under the terms of the termination agreement, AMAG will regain all
worldwide development and commercialization rights for Feraheme/Rienso.
Takeda will make a payment to AMAG in connection with the termination
and will provide certain transition services to AMAG for up to 180 days
after the marketing authorization transfer in each territory. In
addition, both parties will undertake a transfer of the regulatory
files for the product in each respective territory, and Takeda will not
participate in any future development or commercialization activities.
Takeda has been commercializing Feraheme in Canada and Rienso in the EU
for the treatment of iron deficiency anemia (IDA) in patients with
chronic kidney disease (CKD). In both of these territories, Takeda has
submitted applications to expand the product's current label to include
all patients with IDA regardless of underlying cause. AMAG will be
assessing various alternative commercialization strategies for Feraheme
in Canada and Rienso in the EU based, in part, on the pending
regulatory decisions which are expected in 2015.
About Feraheme(R) (ferumoxytol)/Rienso
Feraheme received marketing approval from the FDA on June 30, 2009 for
the treatment of IDA in adult CKD patients and was commercially
launched by AMAG in the U.S. shortly thereafter. Ferumoxytol is
protected in the U.S. by five issued patents covering the composition
and dosage form of the product. Each issued patent is listed in the
FDA's Orange Book, the last of which expires in June 2023.
Ferumoxytol received marketing approval in Canada in December 2012,
where it has been marketed by Takeda as Feraheme, and in the European
Union in June 2013 where it has been marketed by Takeda as Rienso.
Ferumoxytol received marketing approval in Switzerland in August 2013.
Feraheme/Rienso is contraindicated in patients with known
hypersensitivity to Feraheme/Rienso or any of its components. Serious
hypersensitivity reactions, including anaphylactic-type reactions, have
been reported in patients receiving Feraheme/Rienso. Serious adverse
reactions of clinically significant hypotension have been reported in
the post-marketing experience of Feraheme/Rienso.
For additional U.S. product information, including full prescribing
information, please visit www.feraheme.com.
About AMAG
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company with a
focus on maternal health, anemia and cancer supportive care. The
primary goal of AMAG and its maternal health division, Lumara
Health(TM), is to bring to market therapies that provide clear benefits
and improve patients' lives. In addition to continuing to pursue
opportunities to make new advancements in patients' health and to
enhance treatment accessibility, AMAG intends to continue to expand and
diversify its portfolio through the in-license or purchase of
additional pharmaceutical products or companies. For additional company
information, please visit www.amagpharma.com.
AMAG PHARMACEUTICALS(R) is a registered trademark of AMAG
Pharmaceuticals, Inc. LUMARA HEALTH(TM) is a trademark of Lumara Health
Inc.
AMAG Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA)
and other federal securities laws. Any statements contained herein
which do not describe historical facts, including among others,
statements regarding Takeda's payments and services to AMAG, worldwide
development and commercialization rights for Feraheme/Rienso for IDA
and/or CKD, the transfer of regulatory files by Takeda in each
respective territory and AMAG's assessment of commercialization
strategies for Feraheme/Rienso in Canada and the EU are forward-looking
statements which involve risks and uncertainties that could cause
actual results to differ materially from those discussed in such
forward-looking statements.
Such risks and uncertainties include, among others: (1) limitations on
AMAG's ability to invest in the development and commercialization of
Feraheme/Rienso outside the U.S., especially in light of AMAG's being
highly leveraged, (2) AMAG may not be able to successfully
commercialize Feraheme/Rienso using alternate strategies in Canada and
the EU, or may choose not to do so, (3) uncertainties regarding the
likelihood and timing of potential approval of Feraheme/Rienso in the
U.S., the EU and Canada in the broader IDA indication in light of the
complete response letter AMAG received from the FDA informing AMAG that
its supplemental new drug application (sNDA) for the broader indication
could not be approved in its present form and stating that AMAG has not
provided sufficient information to permit labeling of Feraheme/Rienso
for safe and effective use for the proposed broader indication and
similar concerns raised by European and Canadian regulators, (4) the
possibility that following review of post-marketing safety data,
including reports of serious anaphylaxis, cardiovascular events, and
death, and/or in light of the label changes requested by the European
Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee
(PRAC) and confirmed by the Committee for Medicinal Products for Human
Use (CHMP), the FDA, European or Canadian regulators will request
additional technical or scientific information, new studies or
reanalysis of existing data, on-label warnings, post-marketing
requirements/commitments or risk evaluation and mitigation strategies
(REMS) in the current CKD indication for Feraheme/Rienso, or cause
Feraheme/Rienso to be withdrawn from the market, and the additional
costs and expenses that will or may be incurred in connection with such
activities, (5) whether AMAG's proposed label changes will be
acceptable to the FDA or other regulatory authorities and what impact
such changes, or such additional changes as U.S. and/or non-U.S.
regulators may require, will have on sales of Feraheme/Rienso, (6)
AMAG's ability to successfully compete in the IV iron replacement
market both in the U.S. and outside the U.S. as a result of
limitations, restrictions or warnings in Feraheme's/Rienso's current or
future label, including the changes recommended by PRAC and confirmed
by CHMP that Rienso be administered to patients by infusion over at
least 15-minutes (replacing injection) and that it be contraindicated
for patients with any known history of drug allergy, (7) the
possibility that significant safety or drug interaction problems could
arise with respect to Feraheme/Rienso and in turn affect sales or
AMAG's ability to market the product both in the U.S. and outside of
the U.S., (8) AMAG's patents and proprietary rights both in the U.S.
and outside the U.S., (9) the risk of an Abbreviated New Drug
Application (ANDA) filing for Feraheme, especially following the FDA's
draft bioequivalence recommendation for ferumoxytol published in
December 2012, (10) the impact on sales if AMAG disseminates future
Dear Healthcare Provider letters in the U.S., Europe, Canada or other
markets, (11) AMAG's ability to execute on its long-term strategic plan
or to realize the expected results from its long-term strategic plan,
(12) the possibility that AMAG will not realize expected synergies and
other benefits from its acquisition of Lumara Health, as well as AMAG's
ability to pursue additional business development opportunities,
especially in light of AMAG's being highly leveraged and (13) other
risks identified in AMAG's filings with the U.S. Securities and
Exchange Commission (SEC), including its Quarterly Report on Form 10-Q
for the quarter ended September 30, 2014 and subsequent filings with
the SEC. Any of the above risks and uncertainties could materially and
adversely affect AMAG's results of operations, its profitability and
its cash flows, which would, in turn, have a significant and adverse
impact on AMAG's stock price. Use of the term "including" in the two
paragraphs above shall mean in each case "including, but not limited
to." AMAG cautions you not to place undue reliance on any
forward-looking statements, which speak only as of the date they are
made.
AMAG disclaims any obligation to publicly update or revise any such
statements to reflect any change in expectations or in events,
conditions or circumstances on which any such statements may be based,
or that may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with
its main focus on pharmaceuticals. As the largest pharmaceutical
company in Japan and one of the global leaders of the industry, Takeda
is committed to strive towards better health for people worldwide
through leading innovation in medicine. Additional information about
Takeda is available through its corporate website, www.takeda.com.
Takeda Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking
statements include statements regarding Takeda's plans, outlook,
strategies, results for the future, and other statements that are not
descriptions of historical facts. Forward-looking statements may be
identified by the use of forward-looking words such as "may,"
"believe," "will," "expect," "project," "estimate," "should,"
"anticipate," "plan," "assume," "continue," "seek," "pro forma,"
"potential," "target," "forecast," "guidance," "outlook" or "intend" or
other similar words or expressions of the negative thereof.
Forward-looking statements are based on estimates and assumptions made
by management that are believed to be reasonable, though they are
inherently uncertain and difficult to predict. Investors are cautioned
not to unduly rely on such forward-looking statements.
Forward-looking statements involve risks and uncertainties that could
cause actual results or experience to differ materially from that
expressed or implied by the forward-looking statements. Some of these
risks and uncertainties include, but are not limited to, (1) the
economic circumstances surrounding Takeda's business, including general
economic conditions in Japan, the United States and worldwide; (2)
competitive pressures and developments; (3) applicable laws and
regulations; (4) the success or failure of product development
programs; (5) actions of regulatory authorities and the timing thereof;
(6) changes in exchange rates; (7) claims or concerns regarding the
safety or efficacy of marketed products or product candidates in
development; and (8) integration activities with acquired companies.
The forward-looking statements contained in this press release speak
only as of the date of this press release, and Takeda undertakes no
obligation to revise or update any forward-looking statements to
reflect new information, future events or circumstances after the date
of the forward-looking statement. If Takeda does update or correct one
or more of these statements, investors and others should not conclude
that Takeda will make additional updates or corrections.
CONTACT: AMAG Pharmaceuticals, Inc.:
Katie Payne, 617-498-3303
Takeda Pharmaceuticals Company Limited:
Corporate Communications Dept.
+81-3-3278-2037